Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

Completed · Phase 2

Conditions studied: COVID-19

In brief

Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.

Key facts

Study ID

NCT04355143

Run by

University of California, Los Angeles

People needed

93

Starts

2020-05-01

Expected to finish

2021-07-21

Last updated by the study team

2022-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed COVID-19 infection by polymerase chain reaction
• Cardiac injury, including any of the following:
• Elevated troponin level
• Elevated B-type natriuretic peptide (BNP) level
• New ischemic or arrhythmogenic changes on ECG/telemetry
• New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
• Able to provide informed consent

You may not qualify if…

• Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:
• Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
• Hormone methods with a barrier method
• Two barrier methods
• If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
• Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport system inhibitors
• Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
• Severe hematologic or neuromuscular disorders
• Severe renal impairment with concomitant hepatic impairment

Where it is running

• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• UCLA Santa Monica Hospital — Santa Monica, California, United States
• Miami Cardiac and Vascular Institutde, Baptist Health South Florida — Miami, Florida, United States

Full record on ClinicalTrials.gov

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